district of massachusetts mdl no. 13-02419 …€¦ · in fall 2012, health officials ... # 176);...

1 A detailed account of the background of the case is set forth in previous opinions of the court. See, e.g., In re New England Compounding Pharm., Inc. Prods. Liability Litig., 496 B.R. 256, 260-263 (D.Mass. 2013). Only a brief summary is set forth here.

UNITED STATES DISTRICT COURTDISTRICT OF MASSACHUSETTS

MDL NO. 13-02419-RWZ

IN RE: NEW ENGLAND COMPOUNDING PHARMACY, INC. PRODUCTS LIABILITY LITIGATION

MEMORANDUM OF DECISION

August 29, 2014

ZOBEL, D.J.

This multidistrict litigation stems from an outbreak of fungal meningitis caused by

contaminated methylprednisolone acetate (“MPA”) manufactured and sold by the New

England Compounding Pharmacy, Inc., d/b/a New England Compounding Center

(“NECC”). Before the court now are several motions to dismiss under Fed. R. Civ P.

12(b)(6), filed by clinic-related defendants from Tennessee and New Jersey, based on

alleged noncompliance with certain state law requirements and failure to state a claim

on which relief can be granted.

I. Background1

A. Factual and Procedural History

NECC operated a compounding pharmacy in Framingham, Massachusetts, that

combined and mixed ingredients to create specific formulations of pharmaceutical

products. In fall 2012, health officials traced a number of cases of fungal meningitis to

Case 1:13-md-02419-RWZ Document 1360 Filed 08/29/14 of 64

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injections in and around the patients’ spinal cords of MPA that had been manufactured

by NECC. NECC initiated a recall of several contaminated batches of MPA before

eventually surrendering its pharmacy license and ceasing production of all

pharmaceutical products. NECC filed for Chapter 11 bankruptcy in December 2012.

Lawsuits alleging death or injury based on contaminated MPA were filed against

NECC, affiliated entities and individuals, and/or health care providers in multiple state

and federal jurisdictions around the country beginning in November 2012. In February

2013, the Judicial Panel on Multidistrict Litigation (“JPML”) issued an order under 28

U.S.C. § 1407 transferring various federal court matters to this court for coordinated

and consolidated pretrial proceedings; subsequent JPML orders also transferred “tag-

along” cases. Other cases pending in both federal and state court were likewise

transferred to this court via additional transfer orders. See In re New England

Compounding Pharm., Inc. Prods. Liability Litig., 496 B.R. 256 (D. Mass. 2013) (Docket

# 176); In re New England Compounding Pharm., Inc. Prods. Liability Litig., Civil Action

No. 13-02419-RWZ, 2014 WL 2040139 (D. Mass. May 15, 2014) (Docket # 1131);

June 4, 2014, Transfer Order (Docket # 1173).

On November 5, 2013, in accordance with MDL Order No. 6 (Docket # 209), the

court-appointed plaintiffs’ steering committee filed a master complaint against

numerous non-NECC parties, including hospitals, clinics, and health care facilities (as

well as their physicians, staff, agents, and employees), that allegedly obtained


2 The master complaint was intended to be an administrative tool, allowing the allegations andclaims against all defendants to be stated in one document.

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contaminated MPA from NECC and administered it to their patients.2 See Master

Complaint (“Master Compl.”), Docket # 545. Plaintiffs who already had cases on file or

who wished to file in the multidistrict litigation thereafter submitted short-form

complaints to assert facts and claims set out in the master complaint. A substantial

number of short-form complaints name “clinic-related defendants” from Tennessee and

New Jersey, several of whom filed the motions at bar.

B. The Movants

As set forth in the parties’ memoranda, the movants are aligned in the following

groups:

1. The Tennessee Clinic Defendants

Defendant St. Thomas Outpatient Neurosurgical Center, LLC (“STOPNC”) is a

licensed ambulatory surgery center located in Nashville, Tennessee. STOPNC

purchased contaminated MPA from NECC and administered it to patients. Defendant

Howell Allen Clinic, P.C. (“Howell Allen”), a neurosurgical group in Nashville, owns a

50% interest in STOPNC and staffs STOPNC pursuant to a management contract.

Defendant John W. Culclasure, M.D., is an employee of Howell Allen and the medical

director of STOPNC. Dr. Culclasure participated in the decision to purchase MPA from

NECC for use at STOPNC and performed epidural steroid injections using that MPA.

Defendant Debra V. Schamberg, R.N., an employee of Howell Allen and the facility

director of STOPNC, also participated in the decision to purchase MPA from NECC for


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use at STOPNC. STOPNC, Howell Allen, Dr. Culclasure, and Ms. Schamberg have

been named, in various combinations, in suits filed by or on behalf of 117 patients.

Defendant Specialty Surgery Center, Crossville, PLLC (“SSC”) is a licensed

ambulatory surgery center in Crossville, Tennessee, that purchased contaminated MPA

from NECC. Defendant Kenneth R. Lister, M.D., the owner of SSC, participated in the

decision to purchase MPA from NECC for use at SSC and performed epidural steroid

injections using that MPA. Dr. Lister is the sole owner and employee of his practice,

defendant Kenneth Lister M.D., P.C. SSC is a defendant in suits filed by or on behalf

of 24 patients; Dr. Lister is named in 11 of those actions, and his practice is named in

five.

2. The Saint Thomas Entities (Tennessee)

The Saint Thomas Entities are comprised of defendants Saint Thomas West

Hospital (formerly known as St. Thomas Hospital), Saint Thomas Network, and Saint

Thomas Health. Saint Thomas Health owns both Saint Thomas West Hospital and

Saint Thomas Network, which in turn is a co-owner of STOPNC with Howell Allen. The

Saint Thomas Entities are named in vicarious liability claims in dozens of short-form

complaints based on their alleged relationship with STOPNC.

3. The Ascension Parties (Tennessee)

The Ascension Parties are defendants Ascension Health Alliance and Ascension

Health, which owns Saint Thomas Health. Some plaintiffs with claims against the Saint

Thomas Entities have also asserted vicarious liability claims against the Ascension

Parties.


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4. The Premier Defendants (New Jersey)

Defendant Premier Orthopaedic Associates and Sports Medicine Associates of

New Jersey, LLC (trading as Premier Orthopaedic Associates) is an orthopedic practice

located in Vineland, New Jersey, whose providers performed epidural injections of

contaminated MPA obtained from NECC. Most of the injections were administered at

defendant Premier Orthopaedic Associates Surgical Center, LLC, and were performed

by defendant Kimberley Yvette Smith, M.D., a/k/a Kimberly Yvette Smith-Martin, M.D.

The Premier Defendants have been named in ten actions.

C. The Motions to Dismiss

The motions to dismiss fall into two categories. The first, brought by the

defendants from Tennessee (Docket ## 770 and 779), seeks dismissal for plaintiffs’

alleged failure to comply with the Tennessee Health Care Liability Act (“THCLA”). The

second set of motions focuses on “global claims,” i.e., claims against defendants

alleged in all or a substantial number of cases. Each group of the above defendants

has filed a separate “global claims” motion: the Tennessee Clinic Defendants (Docket #

771), the Saint Thomas Entities (Docket # 893), the Ascension Parties (Docket # 895),

and the Premier Defendants (Docket # 831).

The motions will be addressed seriatim by category.

II. Legal Standard

“To survive a motion to dismiss, a complaint must contain sufficient factual

matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’”

Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atlantic Corp. v. Twombly, 550


6

U.S. 544, 570 (2007). Plausibility “is not akin to a probability requirement, but

[requires] more than a sheer possibility that a defendant has acted unlawfully.” Iqbal,

556 U.S. at 678. Thus, “[a] pleading that offers ‘labels and conclusions’ or ‘a formulaic

recitation of the elements of a cause of action will not do.’” Id. When ruling on a

motion to dismiss under Fed. R. Civ. P. 12(b)(6), the court accepts as true all factual

allegations contained in the complaint, but not legal conclusions. Id.

III. Discussion

A. Motions to Dismiss for Failure to Comply with the Tennessee HealthCare Liability Act (Docket ## 770 and 779)

The Tennessee Clinic Defendants, Saint Thomas Entities, and Ascension

Parties assert that plaintiffs have failed to comply with the Tennessee Health Care

Liability Act (“THCLA”), Tenn. Code Ann. § 29-26-101, et seq., which establishes

mandatory requirements that a Tennessee plaintiff must meet prior to filing a health

care liability action, including giving pre-suit written notice and filing a certificate of

good faith. Defendants argue that deficiencies cannot be cured by amendment and

that noncompliance warrants dismissal.

Plaintiffs counter that the THCLA does not apply to any original complaints that

brought only claims for products liability against defendants. Plaintiffs later amended

these complaints to add health care liability claims, at which point they did issue pre-

suit notices and file certificates of good faith under the THCLA. Plaintiffs also assert

that even if the THCLA were to apply to their original complaints, strict compliance is

not necessary and prejudice must be shown before dismissal.


3 The “Affiliated Parties” are certain individuals and entities closely associated with NECC. Theyinclude Barry Cadden, Lisa Cadden, Greg Conigliaro, Douglas Conigliaro, and Carla Conigliaro – whotogether founded and ran NECC – as well as pharmacist Glenn A. Chinn and related companiesAmeridose, LLC, Medical Sales Management, Alaunus Pharmaceutical LLC, and GDC Holdings Inc.and/or GDC Properties Management LLC. See Master Compl. at ¶¶ 24-41.

4 “HIPAA” is an acronym for the Health Insurance Portability and Accountability Act of 1996, Pub.L. 104-191, 110 Stat. 1936.

7

While defendants allege various specific deficiencies in the relevant complaints

(including those that did bring THCLA claims from the start), the parties agreed in April

2014 to focus and limit their briefing to three key issues, leaving case-specific ones to

be addressed at a later time. The issues are:

(1) Whether plaintiffs were required to identify NECC and the AffiliatedParties3 in pre-suit notices as health care providers that would be named asdefendants and provide HIPAA-compliant4 releases for those parties;

(2) Whether the pre-suit requirements set forth in Tenn. Code Ann. § 29-26-121 apply to plaintiffs filing complaints alleging only claims styled asproducts liability claims and, if so, whether failure to comply with such pre-suit requirements can be cured by a pleading amendment; and

(3) Whether Tenn. Code Ann. § 29-26-122 requires that plaintiffs filingcomplaints alleging only claims styled as products liability claims file acertificate of good faith with the original complaint.

Resolving these questions requires analysis of whether plaintiffs’ claims do in fact fall

under the THCLA; if so, whether plaintiffs complied with the act’s requirements; and if

not, what the consequences of that noncompliance are.

1. The THCLA

The THCLA came to be in 2012, when the Tennessee legislature amended the

Tennessee Medical Malpractice Act (“TMMA”) to replace all references to “medical

malpractice” and “medical malpractice action” with the terms “health care liability” and


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“health care liability action.” See Act of April 23, 2012, ch. 798, § 7, 2012 Tenn. Pub.

Acts. The act was also amended to provide definitions for “health care liability action,”

“health care provider,” and “health care services”:

“Health care liability action” means any civil action, including claims againstthe state or a political subdivision thereof, alleging that a health careprovider or providers have caused an injury related to the provision of, orfailure to provide, health care services to a person, regardless of the theoryof liability on which the action is based.

Tenn. Code Ann. § 29-26-101(a)(1).

“Health care provider” means: (A) A health care practitioner licensed,authorized, certified, registered, or regulated under any chapter of titles 63or 68 ... (D) The employee of a health care provider involved in the provisionof health care services, including but not limited to physicians, nurses,licensed practical nurses, advance practice nurses, physician assistants,nursing technicians, pharmacy technicians, orderlies, certified nursingassistants, technicians and those physicians and nurses employed by agovernmental health facility ...

Tenn. Code Ann. § 29-26-101(a)(2).

Health care services to persons includes care by health care providers,which includes care by physicians, nurses, licensed practical nurses,pharmacists, pharmacy interns or pharmacy technicians under thesupervision of a pharmacist, orderlies, certified nursing assistants, advancepractice nurses, physician assistants, nursing technicians, and other agents,employees and representatives of the provider, and also includes staffing,custodial or basic care, positioning, hydration, and similar patient services.

Tenn. Code Ann. § 29-26-101(b).

It is unclear precisely what impact, if any, the changes in terms and insertion of

definitions had on the scope of the THCLA. One Tennessee court has indicated that

the replacement of “medical malpractice” with “health care liability” had no substantive

effect on the operation of the statute, Moses v. Dirghangi, 430 S.W.3d 371, 380 n.4


9

(Tenn. Ct. App. 2013), and state courts have used the terms interchangeably in recent

cases. However, as relevant here, there is also some suggestion that the amendments

expanded the reach of the act to cover more than just claims of medical negligence.

For example, prior to the amendments, courts regularly differentiated between

claims of medical malpractice and claims of “ordinary negligence.” The Tennessee

Supreme Court in Estate of French v. Stratford House, 333 S.W.3d 546, 556 (Tenn.

2011), a wrongful death suit regarding allegedly negligent care administered in a

nursing home, noted that “[n]ot all cases involving health or medical care automatically

qualify as medical malpractice claims.” Rather,

If the alleged breach of duty of care set forth in the complaint is one that wasbased upon medical art or science, training, or expertise, then it is a claimfor medical malpractice. If, however, the act or omission complained of isone that requires no specialized skills, and could be assessed by the trier offact based on ordinary everyday experiences, then the claim sounds inordinary negligence. ... The [TMMA] applies only to those alleged acts thatbear a substantial relationship to the rendition of medical treatment by amedical professional or concern medical art or science, training, orexpertise.

Id. at 556-57. Thus, the court in Estate of French held that allegations pertaining to

specialized medical or nursing skills and training, such as negligence in “assessing [the

patient’s] condition, developing her initial plan of care, and properly updating that plan

to conform to changes in her condition do indeed sound in medical malpractice.” Id.

However, allegations that the nursing home staff, certified nursing assistants, failed to

provide basic routine services and comply with the care plan’s instructions constituted

claims of ordinary negligence. Moreover, the court found that while the plaintiff could

not assert a negligence per se claim in connection with her medical malpractice


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allegation (“The effect of declaring conduct negligent per se is to hold that conduct is

negligent as a matter of law, ... [which] conflicts with the TMMA’s instruction that ‘there

shall be no presumption of negligence on the part of the defendant’ in a medical

malpractice action”), she could proceed on a negligence per se theory in support of her

claims of ordinary negligence. Id. at 561.

Yet under the recent amendments, claims regarding the conduct of the certified

nursing assistants in Estate of French, which the Tennessee Supreme Court held to be

“ordinary negligence” claims, would arguably be considered part of a “health care

liability action” and therefore subject to the THCLA. The Tennessee Court of Appeals

confirmed as much in Parker v. Portland Nursing & Rehab., No. M2011-02633-COA-

R9-CV, 2012 WL 3776800, at *4 n.4 (Tenn. Ct. App. Aug. 30, 2012), indicating that

“[b]oth parties note that the passage of the Tennessee Civil Justice Act of 2011

[amending the TMMA] ended this distinction [between ordinary negligence and medical

malpractice discussed in Estate of French] and created a new cause of action of a

‘health care liability’ claim.” See also John W. Elder and Joshua R. Walker, The

Tennessee Civil Justice Act of 2011: What a Difference a Day Made, 47-AUG TENN.

B.J. 20, 22 (2011) (positing that while claims against a certified nursing assistant for

failure to assure proper hydration and position as directed in a patient’s plan of care

would previously have been considered ordinary negligence claims, under the new

amendments they would be subject to the statutory requirements of the THCLA).

As explored in greater detail infra, whether and to what extent the new THCLA

similarly subsumes other types of civil claims is at the core of the parties’ debate.


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Defendants insist that the THCLA, by its plain language, was intended to be the

exclusive remedy for plaintiffs bringing any civil claim against a health care provider

related to the provision of health care. Plaintiffs dispute this contention, at least with

respect to certain claims.

Where the THCLA does in fact apply, plaintiffs must comply with several

statutory requirements in bringing their claims. At least 60 days before filing a

complaint based upon health care liability, a plaintiff must give written notice of his or

her potential health care liability claim to “each health care provider that will be named

a defendant.” Tenn. Code Ann. § 29-26-121(a)(1). This pre-suit notice must include:

(A) The full name and date of birth of the patient whose treatment is at issue;

(B) The name and address of the claimant authorizing the notice and therelationship to the patient, if the notice is not sent by the patient;

(C) The name and address of the attorney sending the notice, if applicable;

(D) A list of the name and address of all providers being sent a notice; and

(E) A HIPAA compliant medical authorization permitting the providerreceiving notice to obtain complete medical records from each other providerbeing sent a notice.

Id. at § 29-26-121(a)(2). The THCLA also has a requirement that:

In any health care liability action in which expert testimony is required by §29-26-115, the plaintiff or plaintiff’s counsel shall file a certificate of goodfaith with the complaint. If the certificate is not filed with the complaint, thecomplaint shall be dismissed, as provided in subsection (c), absent ashowing that the failure was due to the failure of the provider to timelyprovide copies of the claimant’s records requested as provided in § 29-26-121 or demonstrated extraordinary cause.


5 Under Tenn. Code Ann. § 29-26-122(a):

The certificate of good faith shall state that:

(1) The plaintiff or plaintiff’s counsel has consulted with one (1) or more experts who haveprovided a signed written statement confirming that upon information and belief they:

(A) Are competent under § 29-26-115 to express an opinion or opinions in the case; and

(B) Believe, based on the information available from the medical records concerning thecare and treatment of the plaintiff for the incident or incidents at issue, that there is agood faith basis to maintain the action consistent with the requirements of § 29-26-115 ...

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Id. at § 29-26-122(a).5 The statute instructs that failure to file a certificate of good faith

in compliance with the THCLA makes an action subject to dismissal with prejudice.

See id. § 29-26-122(c).

A plaintiff in a health care liability action has the burden of proving, by expert

evidence:

(1) The recognized standard of acceptable professional practice in theprofession and the specialty thereof, if any, that the defendant practices inthe community in which the defendant practices or in a similar community atthe time the alleged injury or wrongful action occurred;

(2) That the defendant acted with less than or failed to act with ordinary andreasonable care in accordance with such standard; and

(3) As a proximate result of the defendant’s negligent act or omission, theplaintiff suffered injuries which would not otherwise have occurred.

Id. at § 29-26-115(a). The act indicates that “there shall be no presumption of

negligence on the part of the defendant,” id. at § 29-26-115(c), and that “the jury shall

be instructed that the claimant has the burden of proving, by a preponderance of the

evidence, the negligence of the defendant,” id. at § 29-26-115(d).

2. Were plaintiffs required under the THCLA to identify NECC and


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the Affiliated Parties in pre-suit notices and provide HIPAAreleases allowing defendants to obtain records from thoseparties?

Plaintiffs’ pre-suit notices to the Tennessee Clinic Defendants, Saint Thomas

Entities, and Ascension Parties did not list NECC and the Affiliated Parties nor include

HIPAA releases to obtain medical records from them. Defendants argue that these

omissions run afoul of Tenn. Code Ann. § 29-26-121, which requires that the pre-suit

notice include “a list of the name and address of all providers being sent a notice” and

“a HIPAA compliant medical authorization permitting the provider receiving notice to

obtain complete medical records from each other provider being sent a notice.”

Plaintiffs argue that they were not required to identify NECC and the Affiliated

Parties in the pre-suit notice nor provide HIPAA releases for them because their claims

against NECC and company are not health care liability claims. Plaintiffs maintain that

NECC and the Affiliated Parties acted as drug manufacturers, not as health care

providers, and that their claims against them sound in products liability. As such,

plaintiffs were not required to send them pre-suit notice under the THCLA, and

consequently, were not required to identify those parties as “providers being sent

notice” in their notices to defendants. Moreover, NECC and the Affiliated Parties

expressly waived all state law pre-suit filing requirements, as confirmed by MDL Order

No. 6. In any event, plaintiffs assert that defendants were not deprived of the

opportunity to obtain medical records from NECC and the Affiliated Parties because

those parties did not have any such records; and that since defendants failed to use

even the few medical authorizations they did receive, they cannot show prejudice


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resulting from the lack of authorizations from the remaining plaintiffs.

Defendants reply that NECC and the Affiliated Parties are “health care

providers” as the term is defined in the statute. The claims against them are pled not

expressly as “products liability” but as negligence, negligence per se, negligent

supervision, and public nuisance, and defendants assert that the THCLA subsumed all

such claims against health care providers for injury related to the provision of health

care services under “health care liability.” Even if plaintiffs are not suing NECC or the

Affiliated Parties for health care liability, defendants argue that the trigger for pre-suit

notice only requires that a health care provider be a named defendant in a complaint

alleging health care liability against someone (and here, plaintiffs allege health care

liability against the defendants). Defendants also dispute that NECC and the Affiliated

Parties’ unilateral waiver of pre-suit notice eliminated the need to identify them in the

notices sent to other defendants since the requirement’s primary purpose is to enable

defendants to evaluate the suit and facilitate settlement. Because plaintiffs did not

identify NECC and the Affiliated Parties in the pre-suit notices, defendants claim they

were prejudiced in their evaluation of the case with respect to questions of comparative

fault and venue.

In determining the nature and substance of a claim, Tennessee law directs

courts to look at the “gravamen of the complaint,” irrespective of the designations given

the claims by the parties. Estate of French, 333 S.W.3d at 557. Under that approach,

plaintiffs have the better of the argument. While NECC and the Affiliated Parties, by

virtue of their status as pharmacies, pharmacists, or employees thereof, may fall under


6 C.f. Kelley v. Middle Tennessee Emergency Physicians, P.C., 133 S.W.3d 587, 592 (Tenn.2004) (“A physician-patient relationship is an ‘essential’ or ‘necessary’ element of a medical malpracticeaction.”); Gunter v. Laboratory Corp. of America, 121 S.W. 636, 640 (Tenn. 2003). (“[N]ot all casesinvolving health or medical entities sound in medical malpractice.”).

7 An illustrative case, albeit one that precedes the 2012 amendment adding the definition of“health care provider” to the THCLA, is Debakker v. Hanger Prosthetics & Orthotics East, Inc., 688 F.Supp. 2d 789 (E.D. Tenn. 2010). The plaintiff, a purchaser of a defective leg brace, sued themanufacturer of the brace and an orthotist employed by the manufacturer. Plaintiff alleged that theorthotist, who fitted her for the brace, was negligent in failing to adequately and safely design,manufacture, inspect, and/or test the leg brace before selling and providing it to her; in failing to usereasonable care in fitting, modifying, and altering the brace; and in failing to adequate instruct and/orwarn her as to the brace. She brought claims for negligence, strict products liability, and breach ofwarranty. The defendants filed for summary judgment, arguing that the case must be brought under theTennessee Medical Malpractice Act because the orthotist was a “health care provider.” The courtdisagreed, noting that the role of the orthotist differed from that of a health care provider: “In medicalrelationships like the one at issue is this case, the treating physician diagnoses the medical condition andprovides medical advice to the patient. The orthotist, by contrast, merely carries out the orders of thetreating physician.” Id. at 792. Similarly, here, NECC and the Affiliated Parties did not provide treatmentor medical services to patients (and in fact, had no direct interaction with them at all), but rathercompounded and provided drug products to pain clinics and treating physicians in response to their orderrequests.

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the THCLA’s technical definition of “health care providers,” their role in these cases

was not as providers but as the manufacturers and distributors of MPA. Plaintiffs did

not have a patient-provider relationship with NECC or the Affiliated Parties and, indeed,

were unlikely to have been aware of their existence at the time of the injections.6

Plaintiffs’ claims against NECC and the Affiliated Parties are not really about the

provision of health care services, but about the defects of a product compounded and

sold by NECC; the allegations against them claim negligence in “their design,

compounding, sale, testing, marketing, and distribution of the recalled steroid

medication,” not in administering it to patients.7 See, e.g., Pellicone, et al. v.

Ameridose, et al., 1:13-cv-12916-RWZ, Docket # 1 (“Pellicone Compl.”) at ¶ 202.

That plaintiffs may be bringing health care liability claims against other

defendants does not mean that their claims against NECC and the Affiliated Parties are


16

necessarily or automatically also health care liability claims. Because NECC and the

Affiliated Parties are not being sued as health care providers and therefore were not

sent pre-suit notice under the THCLA, plaintiffs did not need to include them on the

pre-suit notices or HIPAA releases sent to defendants. The motions to dismiss by the

Tennessee Clinic Defendants, Saint Thomas Entities, and Ascension Parties are

therefore denied as to this point.

3. Do the pre-suit notice and good faith certificate requirementsof the THCLA apply to plaintiffs’ original complaints allegingonly products liability claims?

The parties fiercely debate whether the THCLA has any application at all to

plaintiffs’ original complaints alleging only products liability claims against defendants.

Plaintiffs explain that some complaints were initially filed only as products liability

actions due to a timing complication. Under the Tennessee Products Liability Act of

1978 (“TPLA”), a one-year statute of limitations period begins to run on the date when a

plaintiff discovers or reasonably should discover that he was injured by an

unreasonably dangerous or defective product. There is no requirement of pre-suit

notice under the TPLA. In contrast, the THCLA requires plaintiffs to give 60-day written

notice prior to filing suit, after which the one-year statute of limitations is extended by

an additional 120 days. In the case of some plaintiffs, their products liability claims

would have expired before sufficient notice had been given on their health care liability

claims; thus, out of an abundance of caution, these plaintiffs proceeded to file their

TPLA claims while waiting for their THCLA claims to ripen, often expressly indicating

that they intended to later amend their pleadings to add health care liability claims.


8 Whether plaintiffs can bring TPLA claims against defendants at all is addressed in theevaluation of defendants’ motions to dismiss global claims. See infra Part II.B.1.a.

17

These plaintiffs then amended their complaints to add now-ripe THCLA claims and filed

the appropriate documents required by that act.

Defendants assert that the products liability claims, from the start, were

nonetheless governed by the THCLA, which they insist was intended to be the sole

cause of action for claims against health care providers. They argue that because the

act pertains to any suit against a health care provider claiming injury “related to” the

provision of health care services “regardless of the theory of liability on which the

action is based,” Tenn. Code Ann. § 29-26-101(a)(1), plaintiffs’ products liability claims

must comply with the THCLA. Defendants also contend that they are not “sellers”

under the TPLA, arguing instead that they are providers of professional services and

that plaintiffs’ claims (despite the “products liability” title) are, at bottom, about the

provision of health care services.8

Plaintiffs, in contrast, insist that the THCLA pertains only to claims regarding the

provision of health care services, not the sale of goods or products, which are

governed by the TPLA. They note that their products liability claims arise from the

defective and unreasonably dangerous condition of a pharmaceutical product, not from

the services performed while administering that product to patients. Plaintiffs also

maintain that the THCLA’s certificate of good faith requirement only applies to health

care liability actions in which “expert testimony is required,” Tenn. Code Ann. § 29-26-

122(a), related to the defendant’s breach of standard of care. However, TPLA claims

involve strict liability and do not require expert testimony as to a breach of the


18

applicable standard of care.

Once again, we must look at the “gravamen of the complaint” with respect to

these claims, Estate of French, 333 S.W.3d at 557, and consider the scope of the

THCLA. The situation here mirrors the circumstances of Parker, 2012 WL 3776800, at

*1-2, where the plaintiff filed an initial complaint in which she expressly and specifically

stated that she was only asserting claims for ordinary negligence and was not asserting

claims for medical malpractice. She later filed a separate complaint alleging medical

malpractice and complying with the pre-suit requirements of the TMMA. The plaintiff

sought to consolidate the two actions and then to amend her first complaint to add the

medical malpractice claims. The trial court dismissed the second case on the ground

that there was a prior lawsuit pending, and denied the plaintiff’s motion to amend the

first complaint because she failed to comply with the notice requirements of Tenn. Code

Ann. § 29-26-121(a) prior to filing that suit. The appeals court reversed, finding that the

plaintiff’s first complaint indeed only asserted claims for ordinary negligence and

therefore she was not required to comply with the TMMA for those claims: “Plaintiff was

not required to give notice prior to filing her Ordinary Negligence Complaint and

therefore to deny Plaintiff's motion to amend a complaint that did not require pre-suit

notice to add claims for a separate cause of action in which pre-suit notice was

complied with, creates an absurd result.” Id. at *5.

As already noted above, the broad definitions of “health care liability action” and

“”health care services” added to the THCLA in 2012 arguably eliminated the distinction

between medical malpractice and ordinary negligence claims as they pertain to health


19

care services; now all such ordinary negligence claims presumably must proceed under

the THCLA. See Parker, 2012 WL 3776800, at *4 n.4. Nonetheless, it is unclear

whether the amended THCLA has had a similar effect on other types of civil claims

against health care providers – claims which courts had, as with negligence, previously

distinguished from medical malpractice claims under the TMMA.

For instance, in Abeyta v. HC Health Services of Tn., Inc., No. M2011-02254-

COA-R3-CV, 2012 WL 5266321 (Tenn. Ct. App. Sept. 18, 2012), an involuntary

commitment case, the trial court found that all of the plaintiff’s claims were for medical

malpractice and dismissed her complaint for failure to file a certificate of good faith.

The appeals court reversed, finding that the plaintiff had made out claims for, among

other things, medical battery, which “is not a medical malpractice claim governed by the

TMMA,” and negligence per se, “which is not governed by the TMMA.” Id. at *9 and 11.

The court noted in particular that a certificate of good faith was inapt for medical battery

claims, given that expert testimony is not required to sustain such claims, and that the

proof of standard of care for negligence per se was inconsistent with the TMMA’s

requirements. Id. The Sixth Circuit in Shuler v. Garrett, 743 F.3d 170 (6th Cir. 2014),

similarly declined to apply health care liability requirements to a claim for medical

battery despite the fact that the tort of medical battery, by definition, bears a substantial

relationship to the rendition of medical treatment by a medical professional. The court

found no indication that the Tennessee Supreme Court would extend the TMMA to

cover all medical battery claims, and thus chose to “treat the medical battery claim ... as

just that – a medical battery claim – rather than transmuting it into a medical


20

malpractice claim.” Id. at 176. See also Barnett v. Elite Sports Medicine, No. M2010-

00619-COA-R3-CV, 2010 WL 5289669, at *5 (Tenn. Ct. App. 2010) (determining that

plaintiff stated a claim for battery, distinct from allegations of medical malpractice, and

holding that certificate of good faith was therefore not required); Truth v. Eskioglu, 781

F. Supp. 2d 630, 635 n.10 (M.D. Tenn. 2011) (“Even if the [Medical Malpractice] Act

required dismissal of the plaintiff’s malpractice claims, at least a portion of her

intentional misrepresentation claim would go forward. Regardless of whether a plaintiff

has filed a certificate of good faith, the plaintiff’s claims survive to the extent that they

do not require expert testimony.”).

The parties offer no case law, and I have uncovered none, addressing these

issues with respect to the amended THCLA or to products liability claims specifically.

The THCLA’s new definitions are broad and can conceivably be interpreted to span a

wide variety of claims and theories of liability. However, the historical treatment of

other civil claims under the TMMA, the lack of explicit support for defendants’ argument

that the THCLA is now the sole cause of action against health care providers, and the

different showing of proof required for products liability as opposed to claims under the

THCLA all suggest that plaintiffs should be permitted to plead products liability claims

as separate from health care liability. Like the court in Parker, I am loath to require

compliance with THCLA requirements for non-THCLA claims, and therefore rule that

plaintiffs did not have to give pre-suit notice or file certificates of good faith with original

complaints alleging only products liability. See also Fleming v. Saini, No. W2013-

01540-COA-R3-CV, 2014 WL 2592548, at *5 n.7 (Tenn. Ct. App. June 10, 2014) (“Trial


21

courts should be vigilant to guard against misuse of the TMMA as a vehicle for a

defendants to obtain dismissal of a lawsuit that is not primarily a health care liability

action.”). Accordingly, the motions to dismiss by the Tennessee Clinic Defendants,

Saint Thomas Entities, and Ascension Parties for failure to comply with the THCLA with

respect to products liability claims are denied.

4. What are the consequences of noncompliance with theTHCLA?

In cases where the THCLA does apply, the parties dispute what should result

from failure to comply with the act’s pre-suit requirements. The Tennessee Clinic

Defendants, Saint Thomas Entities, and Ascension Parties argue that the THCLA

mandates strict compliance and defects cannot be cured by amendment. Plaintiffs, in

contrast, assert that “substantial compliance” with the technical requirements of the

statutes is sufficient and defendants must demonstrate prejudice to justify dismissal.

Even if there are violations, plaintiffs posit that the court must conduct case-specific

inquiries to determine whether noncompliance should be excused for extraordinary

cause.

The Tennessee Supreme Court directs courts and parties to evaluate

compliance with the THCLA according to the following process:

The proper way for a defendant to challenge a complaint’s compliance withTennessee Code Annotated section 29-26-121 and Tennessee CodeAnnotated section 29-26-122 is to file a ... motion to dismiss. In the motion,the defendant should state how the plaintiff has failed to comply with thestatutory requirements by referencing specific omissions in the complaintand/or by submitting affidavits or other proof. Once the defendant makes aproperly supported motion under this rule, the burden shifts to the plaintiffto show either that it complied with the statutes or that it had extraordinary


22

cause for failing to do so. Based on the complaint and any other relevantevidence submitted by the parties, the trial court must determine whether theplaintiff has complied with the statutes. If the trial court determines that theplaintiff has not complied with the statutes, then the trial court may considerwhether the plaintiff has demonstrated extraordinary cause for itsnoncompliance.

Myers v. AMISUB (SFH), Inc., 382 S.W.3d 300, 307 (Tenn. 2012).

What exactly constitutes compliance, and the consequences of noncompliance,

will depend on the nature of the violation. In general, the statutory requirements that a

plaintiff give pre-suit notice and file a certificate of good faith are “mandatory, not

directory,” Myers, 382 S.W.3d at 308, so health care liability cases in which no notice

was given or a certificate was not filed should be dismissed with prejudice, absent a

showing of “extraordinary cause,” Tenn. Code Ann. § 29-26-121(b) and § 29-26-122(a).

However, the THCLA’s requirements as to the technical content of the pre-suit

notice may, in some instances, be satisfied by substantial compliance. In Stevens ex.

rel. Stevens v. Hickman Community Health Care Services, Inc., 418 S.W.3d 547 (Tenn.

2013), the defendant sought dismissal of the complaint because the plaintiff had failed

to provide HIPAA-compliant medical authorizations as part of pre-suit notice as

required by Tenn. Code Ann. § 29-26-121(a)(2)(E). The Tennessee Supreme Court

determined that not all the subsections of the statute demanded strict compliance.

Rather, the court found that “the touchstone of this analysis is whether a party’s

procedural error resulted in actual prejudice to an opposing party” – thus, strict

compliance would be required only when “essential to avoid prejudicing an opposing

litigant.” Id. at 555. Because “[n]on-substantive errors and omissions [with the HIPAA


9 In so doing, the Stevens court contrasted its remedy with the consequences of failing to file acertificate of good faith, which warrants dismissal with prejudice under the explicit language of thestatute. Id. at 560. The court acknowledged, however, that the dismissal without prejudice effectivelyoperated as a dismissal with prejudice because plaintiff’s claim would then be time-barred. Id.

23

authorization] will not always prejudice defendants by preventing them from obtaining a

plaintiff’s relevant medical records,” the court held that “a plaintiff must substantially

comply, rather than strictly comply, with the requirements of Tenn. Code Ann. § 29-26-

121(a)(2)(E).” Id. The Stevens court then evaluated the plaintiff’s medical

authorization and held that it did not substantially comply with the relevant subsection

due to numerous errors and omissions. Id. at 556. Finding no extraordinary cause to

excuse noncompliance, the court dismissed the complaint without prejudice.9 Id. at

559-60.

Here, it is clear that in cases where plaintiffs were required to give pre-suit

notice and/or file certificates of good faith and yet wholly failed to do so, such errors are

fatal and should result in those complaints being dismissed. However, with respect to

challenges regarding technical content of the pre-suit notice (including the provision of

a HIPAA-compliant authorization), the court must determine the level of compliance

required for that particular subsection, based on whether the “essence and

fundamental purpose” of the notice requirement was met and whether strict compliance

“is essential to avoid prejudicing the opposing litigant.” Thurmond v. Mid-Cumberland

Infectious Disease Consultants, PLC, et al., No. M2012-02270-SC-R11-CV, 2014 WL

1632183, at *7 (Tenn. Apr. 24, 2014). If I find that a plaintiff did in fact fail to comply

(substantially or otherwise) with the THCLA’s requirements, I must then evaluate


10 While there is no precise definition of “extraordinary cause” and most courts have declined tofind it, one court excused noncompliance where plaintiffs commenced suit during a time when the stateof the law on the question of serving pre-suit notice was “unsettled, unclear, and potentially confusing.”Brown v. Samples, No. E2013-00799-COA-R9-CV, 2014 WL 1713773, at *9 (Tenn. Ct. App. Apr. 29,2014).

24

whether extraordinary cause10 exists to excuse the violation. This may, as plaintiffs

suggest, require case-specific inquiry. In any event, there are no allegations of

noncompliance as to specific complaints currently before the court. As agreed to by

the parties, such case-specific issues have been held in abeyance to be resolved at

some later point in this litigation.

B. Motions to Dismiss “Global Claims”

The Tennessee Clinic Defendants, Saint Thomas Entities, Ascension Parties,

and Premier Defendants all filed motions to dismiss certain “global claims” that have

been alleged in all or a substantial number of cases against them. Each motion shall

be addressed separately below.

1. The Tennessee Clinic Defendants’ Motion to Dismiss GlobalClaims (Docket # 771)

Plaintiffs make nine global claims against the Tennessee Clinic Defendants:

negligence, products liability, violation of the Tennessee Consumer Protection Act,

medical battery, informed consent, civil conspiracy, vicarious liability (for the actions of

NECC), “special duty,” and health care liability. The Tennessee Clinic Defendants

assert that all claims except those for health care liability should be dismissed for

failure to state a claim upon which relief can be granted.

The Tennessee Clinic Defendants’ primary argument for dismissal is that

plaintiffs’ claims, regardless of how they are labeled, fall under the purview of the


25

THCLA and therefore must comply with the act. The Tennessee Clinic Defendants

assert that because the complaints all allege injury against them, “health care

providers,” as a result of the administration of medication, a “health care service,” any

claims that fail to comply with THCLA’s requirements, or are somehow inconsistent with

the statute, must be dismissed. In the alternative, even if dismissal is not warranted

under the THCLA, the Tennessee Clinic Defendants urge dismissal of certain claims for

failure to state a claim for various additional reasons.

a. Products Liability

Plaintiffs seek to hold the Tennessee Clinic Defendants strictly liable for the

contaminated MPA under the Tennessee Products Liability Act of 1978 (“TPLA”). The

Tennessee Clinic Defendants argue that they are not “sellers” of the medications they

administer and that plaintiffs’ claims are expressly contrary to the THCLA, which

requires a plaintiff to prove the negligence of the defendant by expert testimony. In

essence, the Tennessee Clinic Defendants maintain that plaintiffs cannot recover from

them under a theory of strict products liability and instead must plead and prove their

case in a manner consistent with the requirements of the THCLA.

The TPLA defines “product liability action” as “all actions brought for or on

account of personal injury, death, or property damages caused by or resulting from the

manufacture, construction, design, formula, preparation, assembly, testing, service,

warning, instruction, marketing packaging or labeling of any product.” Tenn. Code Ann.

§ 29-28-102. The term “includes, but is not limited to, all actions based upon the

following theories: strict liability in tort; negligence; breach of warranty, express or


26

implied; breach of or failure to discharge a duty to warn or instruct, whether negligent,

or innocent; misrepresentation, concealment, or nondisclosure, whether negligent, or

innocent; or under any other substantive legal theory in tort or contract whatsoever.”

Id. The seller of a product may be found strictly liable, with no proof of negligence, if

the product causing injury to a person or property “is determined to be in a defective

condition or unreasonably dangerous at the time it left the control” of the seller. Nye v.

Bayer Cropscience, Inc., 347 S.W.3d 686, 693 (Tenn. 2011) (quoting Tenn. Code Ann.

§ 29-28-105(a)). A products liability action can only be brought against a non-

manufacturer seller, however, in select situations, including (as is relevant here) when

the manufacturer has been judicially declared insolvent. Tenn. Code Ann. § 29-28-106.

The Tennessee Clinic Defendants argue that they are not “sellers” of MPA and

cannot be sued for products liability. A “seller” includes “a retailer, wholesaler, or

distributor, and means any individual or entity engaged in the business of selling a

product, whether such sales is for resale, or for use or consumption.” Tenn. Code Ann.

§ 29-28-102(7). The Tennessee Clinic Defendants claim that, under Tennessee law,

providers of professional services are not sellers of items used during the provision of

those services. They cite two Tennessee cases in support: Parker v. Warren, 503

S.W.2d 938, 945 (Tenn. Ct. App. 1973), in which several carpenters were held not to

be sellers of the defective lumber used to construct bleachers, and Delta Refining Co.

v. Procon, Inc., 552 S.W.2d 387, 389 (Tenn. Ct. App. 1976), in which a general

contractor was held not to be the “seller” of a defective pump, but rather “merely

contracted with [the plaintiff] to purchase and install a pump which [the manufacturer]


27

would build according to specifications furnished by Plaintiff.” The Tennessee Clinic

Defendants acknowledge that Tennessee has not specifically addressed whether

health care providers can be held strictly liable as sellers, but urge the court to

nonetheless follow the example of numerous other jurisdictions that have explicitly held

that health care providers are not sellers of the items consumed during the provision of

health care services.

Plaintiffs, however, note that neither Parker nor Delta Refining held definitively

that providers of professional services are not sellers, but rather that the specific

defendants at issue in those cases were not “sellers” because they neither selected nor

sold the subject products. In contrast, plaintiffs allege that the Tennessee Clinic

Defendants were in fact engaged in “selling” MPA, selecting the steroid and charging

patients for it separately and apart from monies charged for the services of the

physicians administering the injections. They argue that patients visited the Tennessee

clinics not to receive services, but to receive a product to relieve their back pain.

Plaintiffs also contend that unique provisions of the TPLA indicate that health

care providers can be considered sellers of harmful or defective products. Section 103

of the TPLA, which sets forth time limitations on product liability actions, contains a

special extension of the statute of repose for actions based on injury resulting from

silicone gel breast implants:

(c)(1) Any action against a manufacturer or seller for injury to person causedby a silicone breast implant must be brought within a period not to exceedtwenty-five (25) years from the date such product was implanted; provided,that such action must be brought within four (4) years from the date theplaintiff knew or should have known of the injury.


28

(2) For purposes of this subsection (c) only, “seller” does not include ahospital or medical facility where the procedure took place, nor does “seller”include a physician or other medical personnel involved in the procedure.

Tenn. Code Ann. § 29-28-103 (emphasis added). Plaintiffs assert that the specific

carve-out of health care providers from the definition of “seller” in § 29-28-103 (c)(2)

logically implies that health care providers can be held liable as sellers in cases

involving products other than silicone breast implants.

This court’s case law research did not unearth any Tennessee cases in which

products liability claims were successfully brought against health care providers, nor

any cases indicating that health care providers were categorically not sellers or could

not be sued under the TPLA. The absence of a clear precedent prohibiting products

liability actions against health care providers and the statutory language cited by

plaintiffs above strongly militate against barring such claims.

Even assuming the Tennessee Clinic Defendants can be considered sellers, the

question remains whether plaintiffs can bring TPLA claims in light of the THCLA. As

already discussed to some degree in the prior section, the Tennessee Clinic

Defendants contend that plaintiffs’ products liability claims are clearly “related to the

provision of ... health care services,” Tenn. Code Ann. § 29-26-101(a)(1), and thus

must comply with the THCLA. Moreover, they assert that plaintiffs’ claims for strict

products liability are contrary to the THCLA’s requirement that a defendant’s

negligence be proven through expert testimony and therefore must be dismissed as

inconsistent with the THCLA. Plaintiffs disagree with the Tennessee Clinic Defendants’

broad reading of the THCLA’s scope and insist that their products liability claims are


29

about the sale of a product, not the provision of health care services. They also argue

that the inconsistency in burdens of proof between the two statutes does not warrant

the dismissal of their TPLA claims but rather bolsters their position that products

liability claims are separate from health care liability claims.

As of the date of this opinion, there are no cases dealing with the interaction of

products liability claims with the THCLA. But the Tennessee Clinic Defendants cite to

an older case, Burris v. Hospital Corp. of America, 773 S.W.2d 932 (Tenn. Ct. App.

1989), based on Tennessee’s Medical Malpractice Review Board and Claims Act of

1975, the TMMA’s predecessor. There, the plaintiff’s wife underwent a surgical

procedure to remove a portion of her lung; the surgeon used Teflon felt “pledgets” to

support sutures in the closure of the lung. The presence of the pledgets enhanced the

perpetuation of an infection in the lung, requiring its eventual removal and later

contributing to the patient’s death. The plaintiff brought a wrongful death action against

the hospital, which argued that the case was barred by the statute of limitations of the

Medical Malpractice Review Board and Claims Act. That act had previously contained

a definition of “medical malpractice action” – repealed at the time of the lawsuit, but in

effect at the time of the surgical procedure – as “any action for damages for personal

injury or death as a result of any medical malpractice by a health care provider,

whether based upon tort or contract law.” Id. at 934. The plaintiff contended that the

suit “involves the characteristics of a products liability case which is not comprehended

within the Medical Malpractice Review Board and Claims Act,” but the Tennessee Court

of Appeals disagreed given the act’s inclusive language of “whether based upon tort or


30

contract law.” Id. The court reasoned that this phrase “must include all civil wrongs”

and thus any ground stated by the plaintiff for the recovery of civil damages must be

within the statutory definition of “medical malpractice.” Id. at 935.

The Tennessee Clinic Defendants argue that the THCLA is even more

expansive than the Medical Malpractice Review Board and Claims Act, and so the

Burris court’s reasoning applies here. This argument has some force. The THCLA’s

language is indeed broad, and a literal reading of “any civil action ... regardless of the

theory of liability on which the action is based,” Tenn. Code Ann. § 29-26-101(a)(1),

seemingly could encompass plaintiffs’ products liability claims. But plaintiffs contend

that evaluating products liability claims as health care liability claims would unjustifiably

expand the THCLA and conflict with decades of TPLA precedents without an express

directive to that effect from the legislature.

“Federal courts hearing diversity matters should be extremely cautious about

adopting substantive innovation in state law.” Shuler, 743 F.3d at 176 (quoting Combs

v. International Ins. Co., 354 F.3d 568, 578 (6th Cir. 2004). See also Dayton v. Peck,

Stow, and Wilcox Co. (Pexto), 739 F.2d 690, 694 (1st Cir. 1984) (“[W]e are in

particularly poor position, sitting as a federal court in a diversity case, to endorse [a]

fundamental policy innovation .... Absent some authoritative signal from the legislature

or the courts of [the state], we see no basis for even considering the pros and cons of

innovative theories ....”). Here, plaintiffs have adequately stated claims for relief under

the TPLA, apart from allegations of health care liability. Given the lack of controlling

authority to the contrary, plaintiffs may proceed with their products liability claims as


11 Notwithstanding this ruling, plaintiffs cannot prosecute their products liability claims againstdefendants who are not alleged to have sold the MPA, i.e., the charge for the drug did not come fromthem. It is unclear at this juncture who those individuals or entities may be.

31

separate from the THCLA.11 See Shuler, 743 F.3d at 176.

b. Tennessee Consumer Protection Act

The Tennessee Clinic Defendants seek dismissal of plaintiffs’ claims under the

Tennessee Consumer Protection Act (“TCPA”), Tenn. Code Ann. § 47-181-101, et seq.,

as inconsistent with the THCLA. In the alternative, they assert that Tennessee law

does not permit recovery for losses flowing from personal injury or wrongful death, nor

allow claims concerning the provision of medical services, under the TCPA.

The TCPA makes unlawful “unfair or deceptive acts or practices affecting the

conduct of any trade or commerce.” Tenn. Code Ann. § 47-18-104. The act allows for

individual private actions to recover actual damages for “an ascertainable loss of

money or property, real, personal, or mixed, or any other article, commodity, or thing of

value wherever situated, as a result of the use or employment by another person of an

unfair or deceptive act or practice described in § 47-18-104(b).” Id. at § 47-18-

109(a)(1).

The master complaint alleges that “[h]ad Clinic Related Defendants not engaged

in the deceptive conduct described herein, Plaintiffs would not have allowed for the

administration of NECC Contaminated Drugs, and would not have incurred related

medical costs and injury, and at times, death.” Master Compl. at ¶ 260. The

Tennessee Clinic Defendants are correct that plaintiffs cannot recover under the TCPA


12 Plaintiffs also allege losses for the monies used to purchase the MPA from the TennesseeClinic Defendants. Master Compl. at ¶ 263. These losses may be recoverable under the TCPA.

32

for damages flowing from personal injury or wrongful death.12 In Kirksey v. Overton

Pub, Inc., 804 S.W.2d 68, 73 (Tenn. Ct. App. 1990), the Tennessee Court of Appeals

rejected the plaintiffs’ assertion that their son’s life was “a thing of value” under § 47-

18-109 and found that the TCPA was intended to be used only by a person claiming

damages for loss of money or property, not in a wrongful death action. Similarly, in

Akers v. Prime Succession of Tennessee, 387 S.W.3d 495, 509 (Tenn. 2012), the

Tennessee Supreme Court held that “an action does not lie under the TCPA for

emotional distress in the absence of pecuniary damages.” See also Howard v. R.J.

Reynolds Tobacco Co., No. 1:05CV-27, 2005 WL 2088909, at * 3 (E.D. Tenn. Aug. 25,

2005) (“[T]he Court must dismiss Plaintiff’s claims to the extent he seeks to recover for

injuries to his person resulting from [defendant’s] alleged violations of the TCPA.”);

Birdsong v. Eli Lilly and Co., No. 3:10-01182, 2011 WL 1259650 at *3 (M.D. Tenn. Mar.

31, 2011) (dismissing TCPA claims where plaintiffs sought to recover for personal

injuries allegedly suffered as a result of taking defendants’ medication); Riddle v.

Lowe’s Home Centers, Inc., 802 F. Supp. 2d 900, 909 (M.D. Tenn. 2011) (dismissing

TCPA claims for bodily injuries, including sums consequently incurred for medical care,

attendance, and lost income).

The Tennessee Clinic Defendants also assert that plaintiffs’ TCPA claims must

be dismissed because the act does not provide a remedy for claims related to the

provision of medical care. In support, they cite Constant v. Wyeth, 352 F. Supp. 2d

847, 853 (M.D. Tenn. 2003), where the court held that “medical malpractice claims may


33

not be recast as consumer protection act claims” because “the actual practice of

medicine does not affect trade or commerce.” However, the Constant court

acknowledged that it was not making a blanket holding that physicians are entirely

immune from TCPA claims; “[r]ather, they are only immune when the plaintiff’s

allegations concern the actual provision of medical services.” Id. at n.10. Here, again,

plaintiffs allege not only that the Tennessee Clinic Defendants provided medical care,

but that they were sellers of a product (MPA), the nature, quality, and characteristics of

which they allegedly misrepresented. They claim that the Tennessee Clinic

Defendants failed to provide accurate disclosures of all material information before

patients agreed to be injected with the MPA – including important product safety

information – and in many cases represented that patients were receiving FDA-

approved Depomedrol and not NECC’s compounded MPA. See Master Compl. at ¶¶

246-253. Such alleged misrepresentations focus on the drug itself, as opposed to the

provision of medical care or the Tennessee Clinic Defendants’ conduct in administering

the drug.

As with plaintiffs’ products liability claims, there is potential for overlap with

health care liability here. But while “the proper administration of prescribed medicine

is, in fact, medical treatment,” Dunlap v. Laurel Manor Health Care, Inc., 422 S.W.3d

577, 581 (Tenn. Ct. App. 2013), the heart of plaintiffs’ TCPA claims is not that the

Tennessee Clinic Defendants failed to properly administer the MPA, but that they sold

the MPA to plaintiffs on the basis of false and incomplete information. Because these

allegations do not really pertain to the provision of health care services, the THCLA


34

does not apply.

Plaintiffs’ TCPA claims are dismissed to the extent they seek recovery for

personal injuries or wrongful death. However, claims for the recovery of monies used

to purchase MPA survive.

c. Battery and Failure to Warn (Lack of Informed Consent)

The Tennessee Clinic Defendants contend that plaintiffs’ medical battery and

failure to warn (lack of informed consent) claims should be dismissed as inconsistent

with the THCLA and for failure to state a claim.

As previously discussed, supra at Part III.A.3, courts have historically

differentiated between medical battery and medical malpractice, holding that the former

did not fall within the TMMA. See Barnett, 2010 WL 5289669, at *5; Shuler, 743 F.3d

at 176. It is unclear whether the recent amendment of the THCLA had any effect on

that stance as there are no cases addressing medical battery in relation to the revised

statute.

In any event, the Tennessee Clinic Defendants argue persuasively that plaintiffs

have not stated a claim for medical battery. Tennessee distinguishes between claims

for medical battery, “cases in which a doctor performs an unauthorized procedure,” and

claims for lack of informed consent, “cases in which the procedure is authorized but the

patient claims that the doctor failed to inform the patient of any or all the risks inherent

in the procedure.” Blanchard v. Kellum, 975 S.W.2d 522, 524 (Tenn. 1998). If the

patient was aware that the doctor was going to perform the procedure and authorized

performance of that procedure, the case is not one of medical battery. Id. (“The


35

primary consideration in a medical battery case is simply whether the patient knew of

and authorized a procedure.”).

Plaintiffs do not allege that they did not know that the Tennessee Clinic

Defendants would administer an epidural steroid injection, nor do plaintiffs allege that

they did not authorize the Tennessee Clinic Defendants to perform the epidural steroid

injection procedure. Instead, plaintiffs claim that they were “unaware of the substantial

health and safety risk inherent in the use of NECC Contaminated Drugs” and “did not

consent to the injection of contaminated drugs into their bodies.” Master Compl. at ¶

297. In short, plaintiffs do not contend that they did not consent to the procedure, but

that they were not informed of the use of compounded or contaminated medication in

that approved procedure. Such allegations do not state a claim for medical battery

under Tennessee law, and plaintiffs’ battery claims must be dismissed.

As for the lack of informed consent claims, plaintiffs allege that the Tennessee

Clinic Defendants failed to warn them that they were being administered “an unsafe,

unreasonably dangerous drug compounded by NECC rather than a high quality drug

produced by an FDA regulated manufacturer” and failed to inform them of “the risks

and benefits of the procedure[] before it was performed.” Master Compl. at ¶¶ 301-302.

Such allegations must be established with expert testimony regarding “the usual and

customary information given to patients to procure consent in similar situations.”

Blanchard, 975 S.W.2d at 524. The Tennessee Clinic Defendants correctly point out

that lack of informed consent claims are governed by the THCLA. See Tenn. Code


13 That section provides that:

In a health care liability action, the plaintiff shall prove by evidence as required by § 29-26-115 that the defendant did not supply appropriate information to the patient in obtaininginformed consent (to the procedure out of which plaintiff’s claim allegedly arose) inaccordance with the recognized standard of acceptable professional practice in theprofession and in the speciality, if any, that the defendant practices in the community inwhich the defendant practices and in similar communities.

Tenn. Code Ann. § 29-26-118.

36

Ann. § 29-26-118.13 See also Bryant v. HCA Health Services of N. Tennessee, Inc., 15

S.W.3d 804, 808 (Tenn. 2000) (“The claim [of lack of informed consent] ... involves

matters of medical science and requires specialized skills not ordinarily possessed by

lay persons. Accordingly, the defendant is within the purview of the Medical

Malpractice Act (‘Act’), and the plaintiffs’ claims are governed by that Act.”). This does

not mean plaintiffs cannot proceed on their theory of lack of informed consent, but

rather that those allegations will be subsumed under their claims for health care liability

and evaluated under the requirements and framework of the THCLA. See, e.g., White

v. Beeks, No. E2012-02443-COA-R3-CV, 2013 WL 6451764 (Tenn. Ct. App. Dec. 9,

2013) (applying health care liability action requirements to claim for lack of informed

consent).

The Tennessee Clinic Defendants additionally assert, however, that the lack of

informed consent claims against certain defendants should be wholly dismissed. In

Bryant, 15 S.W.3d at 808, the Tennessee Supreme Court, in evaluating Tenn. Code

Ann. § 29-26-118, concluded that “the language of the statute suggests that the legal

duty to obtain consent is imposed only on the physician who orders or directs the

surgical procedure”; the court held that “mere status as one involved in a patient’s care

is insufficient to trigger a statutory duty under the informed consent statute” and a


14 The Tennessee Defendants also seek dismissal of informed consent claims against HowellAllen in certain cases where Dr. Culclasure did not perform injections.

37

hospital generally is not required to procure a patient’s informed consent to procedures

“ordered and performed by non-employee doctors.” Id. at 809-10. The Tennessee

Clinic Defendants therefore contend that informed consent claims against STOPNC,

Ms. Schamberg, SSC, and Dr. Lister’s Practice should be dismissed, since those

entities and individuals were neither the physicians nor the employers of the physicians

who ordered and administered the MPA injections.14 Plaintiffs offer no response to this

argument and do not deny that the identified defendants lacked a duty to obtain

consent under Tennessee law. As such, claims based on lack of informed consent

against those defendants are dismissed. See Hinkle v. Kindred Hosp., No. M2010-

02499-COA-R3-CV, 2012 WL 3799215, at *17 (Tenn. Ct. App. Aug. 31, 2012)

(dismissing lack of informed consent claims against hospital that was not involved in

making the decision to conduct procedure; “while hospital employees may have been

the ones to actually carry out those the [non-employee] doctor’s orders, they neither

had the capacity nor the duty to obtain informed consent from the patient.”).

d. Ordinary Negligence and Gross Negligence

Plaintiffs bring claims of ordinary negligence and gross negligence against the

Tennessee Clinic Defendants, alleging that they, among other things, failed to

appropriately investigate NECC prior to procuring drugs from the pharmacy; failed to

follow certain policies and procedures to ensure such drugs were safe; failed to

adequately supervise and train employees and agents who ordered the drugs; failed to

promptly notify plaintiffs that they were injected with potentially contaminated steroids;


38

and generally failed to exercise reasonable care or conduct due diligence to ensure

they were not injecting contaminated and dangerous drugs into their patients. See

Master Compl. at ¶¶ 226-238. These allegations pertain to the Tennessee Clinic

Defendants’ provision of health care services and thus fall within the purview of the

THCLA. Plaintiffs’ negligence claims, though they need not be entirely dismissed, will

be evaluated under the THCLA and against the recognized standard of acceptable

professional practice as required by the act.

e. Duty to Prevent Foreseeable Harm

Sixty-six of the complaints allege that the Tennessee Clinic Defendants, by

virtue of a special relationship with their patients, owed a duty to protect them from

foreseeable harm caused by NECC. Plaintiffs claim the Tennessee Clinic Defendants

breached that duty by ignoring the risks of bulk pharmacy compounding, purchasing

injectable steroids from NECC in bulk without individual prescriptions, and conspiring

with NECC to hide its wrongful conduct from regulators. See, e.g., Pellicone Compl. at

¶¶ 191-199. Plaintiffs assert that the Tennessee Clinic Defendants are therefore jointly

and severally liable for all harm caused by NECC’s intentional misconduct. In

response, the Tennessee Clinic Defendants argue that these claims fall under the

THCLA and that Tennessee law does not impose a special duty on health care

providers to protect a patient from the intentional actions of a third party.

Under Tennessee law, persons generally have no duty to act to protect others

from dangers or risks except for those they themselves have created. Satterfield v.

Breeding Insulation Co., 266 S.W.3d 347, 357 (Tenn. 2008). Nonetheless, “exceptions


39

arise when certain special relationships exist between the defendant and either the

person who is the source of the danger or the person who is foreseeably at risk from

the danger.” Id. at 359. The Tennessee Clinic Defendants maintain that the special

duty arising from the physician-patient relationship is limited to the protection of third

parties from the reasonably foreseeable actions of the patient and does not flow the

other way. See Bradshaw v. Daniel, 854 S.W.2d 865, 872 (Tenn. 1993) (physician-

patient relationship sufficient to impose an affirmative duty on physician to warn

identifiable third persons in the patient’s immediate family against foreseeable risks

emanating from a patient’s illness). Plaintiffs, however, point to Limbaugh v. Coffee

Medical Center, 59 S.W.3d 73, 81 (Tenn. 2001), where a nursing home was held to

have acted negligently in failing to take reasonable precautions to protect a resident

from the foreseeable risk that she would be assaulted by a staff member known to be

physically aggressive. There is no indication that health care providers like the

Tennessee Clinic Defendants would only be obligated to protect others from their

patients. Rather, “[t]hese relationships create an affirmative duty either to control the

person who is the source of the danger or to protect the person who is endangered.”

Satterfield, 266 S.W.3d at 359-60 (emphasis added).

There will be no liability “where the defendant neither knows nor has the reason

to foresee the danger or otherwise know that precautions are called for.” Limbaugh, 59

S.W.3d at 80 (quoting W. PAGE KEETON ET AL., PROSSER AND KEETON ON THE LAW OF

TORTS § 56, at 385). The Tennessee Clinic Defendants argue that even if a special

relationship existed between them and their patients, plaintiffs point to no facts


15 While the master complaint and plaintiffs’ briefs indicate that the civil conspiracy claim isbrought against the “Tennessee Defendants” or “Clinic Related Defendants,” the actual allegations onlyrecite specific actions by STOPNC, Dr. Culclasure, and Ms. Schamberg while stating that “[u]poninformation and belief, the other Clinic Related Defendants had similar communications with NECC.” Master Compl. at ¶ 349.

40

indicating that the Tennessee Clinic Defendants had actual knowledge that made the

contamination of the MPA foreseeable. However, plaintiffs have alleged in their

complaints that the dangers of bulk pharmacy compounding were well known in the

medical community; that the Tennessee Clinic Defendants did not conduct appropriate

due diligence or investigation into NECC, which had a history of adverse events, prior

to purchasing the steroids; and that the Tennessee Clinic Defendants conspired with

NECC to violate patient safety requirements by sending false lists of patients to NECC

to obtain orders of MPA. See, e.g., Pellicone Compl. at ¶¶ 79, 111-118, 130-136, 161-

163, 187-188, 193-194. These allegations, taken as true, are sufficient to make

foreseeable to the Tennessee Clinic Defendants the risk that the MPA being given to

their patients was somehow deficient or unsafe.

Plaintiffs’ claims for duty to prevent foreseeable harm are essentially grounded

in negligence and pertain to the provision of health care services, which would place

them squarely within the THCLA. Thus, the claims will be evaluated as health care

liability claims, albeit under the theory of the duty to prevent foreseeable harm.

f. Civil Conspiracy

Plaintiffs’ allegations of civil conspiracy, supplemented by an amendment filed

on January 31, 2014 (Docket # 833), assert that the Tennessee Clinic Defendants15

knew that NECC was a compounding pharmacy and that MPA is a controlled substance

that cannot be dispensed without a prescription under Massachusetts law and the


41

requirements of the Massachusetts Board of Registration in Pharmacy, as well as

Tennessee law. See Master Compl. at ¶¶ 337-351. Nonetheless, the Tennessee

Clinic Defendants allegedly acted in concert with the NECC to violate state and federal

law by using “bogus” patient lists to obtain bulk orders of MPA instead of providing

patient-specific names, information, and prescriptions as required by law. For example,

plaintiffs allege that in early- to mid-2012, an NECC representative informed Ms.

Schamberg that NECC needed to receive lists of patients with each order of MPA in

order to comply with the Massachusetts Board of Pharmacy requirements. When Ms.

Schamberg told the NECC representative that she could not predict which patients

would receive MPA and therefore could not provide corresponding lists, the NECC

representative allegedly indicated that any list of patient names would suffice. As a

result, STOPNC allegedly sent NECC lists of patients’ names and addresses even

though the listed patients did not necessarily receive MPA and were, in some cases,

fictitious (e.g., “Mickey Mouse”).

Plaintiffs allege that the Tennessee Clinic Defendants knew or should have

known that their conduct violated state and federal law, and that both defendants and

NECC knew of each other’s common intent to use the falsified patient lists to

circumvent prescription requirements. Plaintiffs further allege that the conspiracy was a

proximate and legal cause to their harm; had the Tennessee Clinic Defendants and

NECC abided by the law requiring individual prescriptions, NECC would not have

logistically been able to produce and sell MPA in bulk, and the Tennessee Clinic

Defendants would have purchased safer, albeit more expensive, MPA from a more


16 The Tennessee Clinic Defendants opine that the only conceivable actionable tort alleged byplaintiffs’ conspiracy allegations is fraud, and that plaintiffs have failed to adequately plead an intent todefraud.

42

reputable, FDA-regulated source, thereby avoiding the fungal meningitis outbreak.

Plaintiffs have alleged with adequate specificity that the Tennessee Clinic

Defendants conspired with NECC to accomplish an unlawful purpose – to obtain MPA

in violation of state and federal laws requiring specific patient prescriptions – including

facts indicating the co-conspirators’ knowledge of the law and their common intent to

avoid it. However, the Tennessee Clinic Defendants are correct that plaintiffs fail to

allege an actionable underlying tort. “It is a general rule that conspiracy cannot be

made the subject of a civil action, unless something is done which, without the

conspiracy, would give a right of action. The damage done is the gist of the action, not

the conspiracy ... [T]he simple act of conspiracy does not furnish a substantive ground

of action.” Levy v. Franks, 159 S.W.3d 66, 82 (Ct. App. Tenn. 2004) (quoting Tenn.

Pub. Co. v. Fitzhugh, 52 S.W.2d 157, 158 (Tenn. 1932)). Here, plaintiffs do not identify

an underlying wrongful tort for the conspiracy and do not allege that any of the violated

statutes or regulations provides a private right of action.16 “It cannot be that a

conspiracy to do a thing is actionable where the thing itself would not be.” Felts v.

Paradise, 158 S.W.2d 727, 729 (Tenn. 1942). See also In re Orthopedic Bone Screw

Products Liability Litigation, 193 F.3d 781, 789-90 (3d Cir. 1999) (“[W]e are unaware of

any jurisdiction that recognizes civil conspiracy as a cause of action requiring no


17 The Tennessee Clinic Defendants also claim that many of plaintiffs’ civil conspiracy claims arebarred by the statute of limitations because they were brought more than one year after “the last overtact committed by the co-conspirators in furtherance of the conspiracy.” Swafford v. Memphis IndividualPractice Ass’n, No. 02A01-9612-CV-00311, 1998 WL 281935, at * 12 (Tenn. Ct. App. Jun. 2, 1998). Plaintiffs counter that the Tennessee Defendants are mistaken and that under controlling case law, thestatute of limitations for tort action, including civil conspiracy, is triggered “when the injury occurs or isdiscovered.” McCroskey v. Bryant Air Conditioning Co., 524 S.W.2d 487, 490 (Tenn. 1975). See alsoHill v. A.O. Smith Corp., 801 F.2d 217, 224 (6th Cir. 1986) (following McCroskey in civil conspiracycase); Blakeney v. Kassel, 1991 WL 87978 (Tenn. Ct. App. 1991) (same). Plaintiffs’ position appears tohave better support. The civil conspiracy claims of Tennessee victims who brought suit less than oneyear after they first began suffering symptoms, and less than one year before information about thealleged conspiracy was first discovered, were timely filed.

43

separate tortious conduct. To the contrary, the law uniformly requires that conspiracy

claims be predicated upon an underlying tort that would be independently actionable

against a single defendant. Because plaintiffs here could not sue an individual

defendant for an alleged violation of the FDCA, it follows that they cannot invoke the

mantle of conspiracy to pursue the same cause of action against a group of

defendants. A claim of civil conspiracy cannot rest solely upon the violation of a

federal statute for which there is no corresponding private right of action.”).

As such, plaintiffs’ civil conspiracy claims are dismissed.17

g. Vicarious Liability

Finally, plaintiffs allege that NECC was an agent of the Tennessee Clinic

Defendants and, therefore, the Tennessee Clinic Defendants are vicariously liable for

the actions of NECC. See Master Compl. at ¶¶ 329-336. They claim that a

consensual fiduciary relationship arose when the Tennessee Clinic Defendants

contracted with NECC to procure compounded drugs from NECC for their patients, and

that NECC consented to act as the Tennessee Clinic Defendants’ agent, and in their


18 The factors are: (1) the right to control the conduct of the work; (2) the right of termination; (3)the method of payment; (4) the freedom to select and hire helpers; (5) the furnishing of tools andequipment; (6) the self-scheduling of work hours; and (7) the freedom to render services to other entities. McInturff, 2009 WL 4878614, at *3.

44

interest, when compounding and delivering its drugs. The master complaint also

alleges that the Tennessee Clinic Defendants controlled the procurement of the drugs

from NECC and that NECC acted within the scope of its agency when it negligently

compounded drugs on behalf of the Tennessee Clinic Defendants. Id. at ¶¶ 330-336.

The Tennessee Clinic Defendants argue that plaintiffs have failed to plead

sufficient facts to establish an agency relationship. They cite to seven factors identified

in McInturff v. Battle Ground Academy of Franklin, No. M2009-00504-COA-R3-CV,

2009 WL 4878614 (Tenn. Ct. App. Dec. 16, 2009), as reflective of an agency

relationship and contend that plaintiffs’ allegations do not support any of them.18

Plaintiffs, however, assert that the seven-factor test relied upon by the Tennessee

Clinic Defendants pertains specifically to determining whether a relationship is that of

employer-employee or general contractor-independent contractor, and it is not

universally used to weigh agency in all instances. Rather, the concept of agency “in its

broadest sense includes every relation in which one person acts for or represents

another.” Kerney v. Aetna Cas. & Sur. Co., 648 S.W.2d. 247, 253 (Tenn. Ct. App.

1982) (quoting Howard v. Haven, 281 S.W.2d 480, 485 (Tenn. 1955)). “Whether an

agency exists ‘is a question of fact under the circumstances of the particular case; and

whether an agency has been created is to be determined by the relation of the parties

as they in fact exist under their agreement or acts.’” White v. Revco Discount Drug


45

Ctrs, Inc., 33 S.W.3d 713, 723 (Tenn. 2001) (quoting McCay v. Mitchell, 463 S.W.2d

710, 715 (Tenn. 1970)).

In any event, the principal’s right to control the actions of the agent is “the

essential test” in determining whether an agency relationship exists, Jack Daniel

Distillery, Lem Motlow, Prop. v. Jackson, 740 S.W.2d 413, 416 (Tenn. 1987), though

also important is the principal’s “exercise of actual control over the agent,” White, 33

S.W.3d at 723. Plaintiffs here allege neither adequately. They claim that the

Tennessee Clinic Defendants “controlled the procurement of drugs from NECC to be

sold and administered to their patients,” Master Compl. at ¶ 335, but absent from the

complaint are any facts indicating that the Tennessee Clinic Defendants had any right

of control, or actually exercised any control, over NECC and its conduct. The

relationship between NECC and the Tennessee Clinic Defendants as described in the

complaint is essentially that of a manufacturer or vendor selling its products to a

purchaser, not of an agent acting on behalf of or under the direction of a principal.

Plaintiffs’ conclusory allegations are insufficient to make out a claim for vicarious

liability.

2. The Saint Thomas Entities’ and Ascension Parties’ Motions toDismiss Global Claims (Docket ## 893 and 895)

The Saint Thomas Entities are named in several plaintiffs’ complaints based on

their relationship with STOPNC, a Tennessee clinic that administered the MPA

injections. Plaintiffs allege that the Saint Thomas Entities are vicariously liable under

the doctrine of respondeat superior for the actions of STOPNC. Specifically, they claim


46

that STOPNC and its physicians, nurses, and employees were the alter egos and/or the

actual or apparent agents of the Saint Thomas Entities for the following reasons:

• The Saint Thomas Network is a co-owner of STOPNC.

• The Saint Thomas Entities and STOPNC share the common “St. Thomas”name.

• STOPNC is located inside the Saint Thomas Medical Plaza on St.Thomas Hospital campus.

• The CEO of St. Thomas Hospital is on the Board of Governors ofSTOPNC.

• The Medical Director of St. Thomas Hospital regularly attendedSTOPNC’s Board of Governors meetings.

• STOPNC conducted its Board of Governors meetings in the St. ThomasHospital board room.

• There was no notice to patients of STOPNC that St. Thomas Hospital wasnot the provider of care or that care provided by STOPNC was not subjectto the control or supervision of St. Thomas Hospital.

• Saint Thomas Health/Network handles STOPNC’s contracting andfinances.

• Once the fungal meningitis outbreak occurred, STOPNC instructedpatients to report to St. Thomas Hospital emergency room for evaluationand treatment.

• STOPNC is grossly undercapitalized and unable to meet its obligations tothe fungal meningitis victims, and STOPNC was used as a businessconduit designed to enrich Saint Thomas and Howell Allen while shiftingthe risk of loss to patients.

See, e.g., Reed v. Ameridose, et al., 1:13-cv-12565-RWZ, Docket # 1 (“Reed Compl.”)

at ¶¶ 275-277, 284-286.

Plaintiffs’ claims against the Ascension Parties – Ascension Health Alliance and


47

Ascension Health – are in turn based on their relationship with the Saint Thomas

Entities. Plaintiffs assert that the Ascension Parties “owned, operated, managed and/or

simply did business, in part, as Saint Thomas Health, and/or Saint Thomas Network,

and/or Saint Thomas West Hospital.” See, e.g., Russell, et al. v. Unifirst Corp, et al.,

No. 1:13-cv-12794-RWZ, Docket # 1 (“Russell Compl.”) at ¶ 241. Their allegations

additionally state that:

• Ascension Health lists Saint Thomas Health as one of its “Hospitals andFacilities” on its website.

• On Ascension Health’s IRS Form 990, Schedule R, Part I, AscensionHealth is listed as the “direct controlling entity” of Saint Thomas Health.

• On Ascension Health’s IRS Form 990, Schedule R, Part III “Identificationof Related Organizations Taxable as a Partnership,” STOPNC is one ofthe entities listed.

Russell Compl. at ¶¶ 241-243.

The Saint Thomas Entities argue plaintiffs have not alleged a sufficient factual

basis for imposing vicarious liability and thus all claims against them should be

dismissed. The Ascension Parties essentially adopt the arguments of the Saint

Thomas Entities in asserting that claims against them should likewise be dismissed.

a. Alter Ego Theory

Plaintiffs allege that STOPNC is the alter ego of the Saint Thomas Entities.

Tennessee law sets forth three required elements for alter ego liability:

(1) The parent corporation, at the time of the transaction complained of,exercises complete dominion over its subsidiary, not only of finances, but ofpolicy and business practice in respect to the transaction under attack, sothat the corporate entity, as to that transaction, had no separate mind, will


48

or existence of its own.

(2) Such control must have been used to commit fraud or wrong, toperpetuate the violation of a statutory or other positive legal duty, or adishonest and unjust act in contravention of third parties’ rights.

(3) The aforesaid control and breach of duty must proximately cause theinjury or unjust loss complained of.

Continental Bankers Life Ins. Co. of the South v. Bank of Alamo, 578 S.W.2d 625, 632

(Tenn. 1979). Other relevant and non-exclusive factors include:

(1) whether there was a failure to collect paid in capital; (2) whether thecorporation was grossly undercapitalized; (3) the nonissuance of stockcertificates; (4) the sole ownership of stock by one individual; (5) the use ofthe same office or business location; (6) the employment of the sameemployees or attorneys; (7) the use of the corporation as an instrumentalityor business conduit for an individual or another corporation; (8) the diversionof corporate assets by or to a stockholder or other entity to the detriment ofcreditors, or the manipulation of assets and liabilities in another; (9) the useof the corporation as a subterfuge in illegal transactions; (10) the formationand use of the corporation to transfer to it the existing liability of anotherperson or entity; and (11) the failure to maintain arms length relationshipsamong related entities.

Federal Deposit Ins. Corp. v. Allen, 584 F. Supp. 386, 397 (E.D. Tenn. 1984).

“‘Generally, no one factor is conclusive in determining whether or not to disregard a

corporate entity’; rather, the courts typically rely upon a combination of factors in

deciding such an issue.” Oceanics Schools, Inc. v. Barbour, 112 S.W.3d 135, 140

(Tenn. Ct. App. 2003) (quoting Schlater v. Haynie, 833 S.W.2d 919, 925 (Tenn. Ct.

App. 1991)).

The Saint Thomas Entities argue that plaintiffs’ allegations, even if proven, fall

short of Tennessee’s high standard for piercing the corporate veil. They contend that,


49

at bottom, all plaintiffs can point to are a common name, proximity of facilities, and

partial ownership. The Saint Thomas Entities also maintain that Tennessee law

requires showing that the corporate form was misused to “sanction a fraud, injustice, or

equivalent misfeasance,” Southeast Texas Inns, Inc. v. Prime Hospitality Corp., 462

F.3d 666, 673 (6th Cir. 2006), and that the “real indicia of alter ego – like commingling

of property, undercapitalization, and diversion of assets” are lacking here, Docket #

894 at 13.

Plaintiffs’ allegations do not sufficiently set forth the elements necessary to apply

the alter ego theory. While they note some connections between the Saint Thomas

Entities and STOPNC, no facts alleged show that the former exercised such control

over the latter such that “the two entities are in fact identical or indistinguishable,”

Edmunds v. Delta, L.L.C., 403 S.W.3d 812, 829 (Tenn. Ct. App. 2012), or that

STOPNC had “no separate mind, will, or existence of its own,” Continental Bankers,

578 S.W.2d at 632. This lack of complete dominion is further highlighted by the fact

that STOPNC was co-owned, staffed, and managed by Howell Allen.

The alter ego allegations against the Ascension Parties are similarly weak.

Aside from the conclusory statement that the Ascension Parties “owned, operated,

managed and/or simply did business, in part, as Saint Thomas Health, and/or Saint

Thomas Network, and/or Saint Thomas West Hospital,” plaintiffs offer little to show that

the Saint Thomas Entities were essentially alter egos of their parent company. The

references to Saint Thomas Health on the Ascension Parties’ IRS forms, even if true,


19 “Apparent agency is essentially agency by estoppel; its creation and existence depend uponsuch conduct by the apparent principal as will preclude him from denying another’s agency.” White v.Methodist Hosp. S., 844 S.W.2d 642, 646 (Tenn. Ct. App. 1992). “Generally, to prove apparent agency,one must establish (1) the principal actually or negligently acquiesced in another party’s exercise ofauthority; (2) the third person had knowledge of the facts and a good faith belief that the apparent agentpossessed such authority; and (3) the third person relied on this apparent authority to his or herdetriment.” Mechs. Laundry Serv. v. Auto Glass Co. of Memphis, 98 S.W.3d 151, 157 (Tenn. Ct. 2002).

50

neither suggest that the Ascension Parties exercised the kind of complete dominion

over the Saint Thomas Entities necessary to find alter ego liability nor speak to the

other relevant factors. At most, they simply indicate that Saint Thomas Health is owned

by Ascension Health and that STOPNC is a related entity for the purposes of federal

taxation.

Plaintiffs’ allegations, to the extent they rely on the alter ego theory, fail to state

a claim for vicarious liability.

b. Agency Theory

Plaintiffs fare better under an agency theory of vicarious liability. As previously

discussed, the concept of agency “includes every relation in which one person acts for

or represents another.” Kerney, 648 S.W.2d at 253 (Tenn. Ct. App. 1982). Plaintiffs

assert that STOPNC, Dr. Culclasure, and Ms. Schamberg were actual and or apparent

agents19 of the Saint Thomas Entities.

The complaints allege that the Saint Thomas Entities owned and operated

STOPNC, managed the contracting and finances of the clinic, and had several

connections to the clinic’s Board of Governors. STOPNC also shares the “Saint

Thomas” name with the Saint Thomas Entities and is located in a building on the

campus of St. Thomas Hospital. Plaintiffs note that STOPNC’s patients had no notice


51

that St. Thomas Hospital was not the provider of care or that care provided by

STOPNC was not subject to the control or supervision of St. Thomas Hospital.

Moreover, once the fungal meningitis outbreak occurred, STOPNC instructed patients

to report to St. Thomas Hospital emergency room for evaluation and treatment.

Plaintiffs claim that they “relied on the reputation of St. Thomas Hospital when

accepting medical care at [STOPNC].” See, e.g., Reed Compl. at ¶ 277.

These allegations are adequate to allege, if not actual agency, at least an

apparent agency relationship between the Saint Thomas Entities and STOPNC, its

physicians, nurses, and employees. See Boren ex rel. Boren v. Weeks, 251 S.W.3d

426, 432-37 (Tenn. 2008) (discussing apparent agency in a hospital context and finding

agency where patients were not adequately informed that emergency-room physicians

were not hospital employees). Under plaintiffs’ allegations, taken as true, the Saint

Thomas Entities held themselves out to the public as providing medical services and

patients receiving care at STOPNC reasonably believed they were being treated by

Saint Thomas employees. Plaintiffs’ claims for vicarious liability against the Saint

Thomas Entities under an agency theory are sufficiently pled.

Plaintiffs do not charge an agency relationship between STOPNC and the

Ascension Parties, and fail to adequately allege agency between the Ascension Parties

and the Saint Thomas Entities. There is no indication from the complaints that the

Saint Thomas Entities were acting on behalf of the Ascension Parties or that patients

believed the Saint Thomas Entities were agents of the Ascension Parties. The


52

Ascension Parties’ motion to dismiss global claims is therefore allowed.

3. The Premier Defendants’ Motion to Dismiss Global Claims(Docket # 831)

The Premier Defendants seek dismissal of various claims for failure to state a

cause of action.

a. Negligence and Failure to Warn

The Premier Defendants contend that plaintiffs’ claims for negligence, gross

negligence, and failure to warn should be dismissed as subsumed by the New Jersey

Products Liability Act (“NJPLA”), N.J.S.A 2A:58C-1, et seq. They argue that the NJPLA

is the exclusive remedy for when an individual is harmed by a product, regardless of

the legal theory supporting the case. The Premier Defendants note that while plaintiffs’

claims are ostensibly rooted in negligence, they actually pertain to the safety of the

medication (i.e., defendants were negligent in not ensuring a “safe” and “clean”

product), and thus must be evaluated under the NJPLA. See, e.g., Port Authority of

New York and New Jersey v. Arcadian Corp., 189 F.3d 305, 313 (3d Cir. 1999) (“Even

though plaintiff alleges a negligence claim in Count I, this count is based solely on

harm caused by defendants’ allegedly defective products. It therefore falls within the

[NJPLA], which is the ‘sole basis under New Jersey law available to consumers injured

by a defective product.’”). Because the NJPLA excludes providers of professional

services as “sellers” under the act, the Premier Defendants conclude that plaintiffs

cannot recover on their negligence claims.

Plaintiffs dispute that NJPLA has any application to their negligence and failure


20 Plaintiffs did not bring separate products liability claims against the Premier Defendants andacknowledge that the NJPLA, unlike the TPLA, codified a common law rule that healthcare providers aregenerally not subject to strict liability claims based upon defective products tangentially used inconnection with medical treatment. See N.J.S.A. 2A:58C-8 (term “product seller” does not include “[a]provider of professional services in any case in which the sale or use of a product is incidental to thetransaction and the essence of the transaction is the furnishing of judgment, skill or services.”).

53

to warn claims.20 They argue that these claims are grounded in the Premier

Defendants’ negligent performance of their medical services in obtaining and

administering the MPA, not in the defectiveness of the MPA itself. For example, the

master complaint alleges that the Premier Defendants failed to exercise reasonable

care to ensure that the drugs they purchased and administered to patients was

manufactured in compliance with applicable pharmaceutical laws, and that they failed

to perform the necessary due diligence to determine the safety and quality of NECC’s

drugs. See Master Compl. at ¶¶ 226-241. The complaint further alleges that the

Premier Defendants failed to investigate whether NECC was a reputable and safe

supplier of sterile injectable compounds and that they purchased such drugs in bulk

from NECC without using patient-specific individual prescriptions as required by law.

Id. Plaintiffs also fault the Premier Defendants for failing to properly inform patients

about the “true nature” of the drug, NECC, and the risks and dangers associated with

the MPA’s administration. Id. at 301-302.

Plaintiffs contend that New Jersey law recognizes negligence and lack of

informed consent as viable claims against health care providers for the negligent

performance of their services even when a defective product may also be involved. In

Snyder v Mekhjian, 582 A.2d 307 (N.J. Super. Ct. App. Div. 1990), a plaintiff who

contracted AIDS as a result of receiving a contaminated blood transfusion during


54

surgery brought strict liability and negligence claims against the physicians, hospital,

and blood bank. He alleged that defendants failed to warn him of the risk of receiving

contaminated blood and did not inform him of other options such as pre-banking his

own blood or receiving donations from family members. He also alleged that the blood

bank negligently failed to implement and follow risk-reducing screening procedures in

the blood-collection process. The court allowed him to proceed on his negligence

claims, even after granting summary judgment on his strict liability claims. Id. at 314

(“What we have said respecting strict liability does not, of course, affect plaintiffs’

remaining negligence causes of action ... . [W]e have no doubt that the viability of the

negligence cause of action against the physicians has been adequately demonstrated.

... [T]here is record support for the proposition that a jury could find that ... the

physician’s duty to inform the patient included advice as to the possibility of AIDS

contamination and the availability of autologous and direct donor transfusion.”).

Similarly, in Johnson v. Mountainside Hosp., 571 A.2d 318, 321-22 (N.J. Super. Ct.

App. Div. 1990), a wrongful death action involving a patient who died after being

disconnected from a respirator, the court dismissed strict liability claims against the

defendant hospital for a defective respirator, but permitted the plaintiff to bring

negligence claims against the hospital and physicians in the performance of their

services. See also New Jersey Courts, Model Civil Jury Charges, c. 5.40A, available at

http://www.judiciary.state.nj.us/civil/charges/5.40A.pdf (noting that since the passage of

the NJPLA, “there is one cause of action for recovery for harm caused by a product” but


55

that “[s]ome negligence actions involving products probably survive the Act.”)

Plaintiffs have sufficiently stated claims for harm caused by alleged negligence

by the Premier Defendants in obtaining and administering the contaminated MPA.

These claims can be considered separate and viable on their own, regardless of

whether defendants are exempt from strict liability under the NJPLA.

b. Battery

The parties’ arguments as to plaintiffs’ battery claims are essentially the same as

those considered with the Tennessee Clinic Defendants. The Premier Defendants

assert that plaintiffs have failed to allege that they did not consent to the injection –

necessary to make out a claim for battery – and instead take issue with the lack of

information given about the risks of NECC’s compounded MPA, which is more

appropriately characterized as an informed consent claim. Plaintiffs respond that they

consented only to the injection of steroids into their bodies, not to “the injection of

contaminated bacterial fungal and bacterial substances” nor to “the administration of

mail-ordered medication from an unaccredited, non FDA approved compounding

pharmacy they have never heard of, [that] was located hundreds of miles away and that

their doctors and their practice had never visited or otherwise seen.” Docket # 980 at

13.

Plaintiffs’ position is untenable. They signed consent forms agreeing to the

procedure (a steroid injection), which is exactly what they received. Plaintiffs’ real

grievance centers on the Premier Defendants’ alleged failure to disclose certain


56

information about the nature of the MPA and risks of the procedure. “[T]he battery

theory should be reserved for those instances where the patient consented to the

performance of one kind of operation and the physician performed a substantially

different one for which authorization was not obtained. ... That does not foreclose a

plaintiff from claiming that the physician was negligent in failing to apprise the patient of

the possible risk attendant to the operation. However he may not properly contend that

the doctor committed an intentional tort, an assault and battery.” Tonelli v. Khanna,

569 A.2d 282, 285-86 (N.J. Super. Ct. App. Div. 1990) (quoting Samoilov v. Raz, 536

A.2d 276 (App. Div. 1987)). Moreover, plaintiffs do not allege that the Premier

Defendants injected the MPA with actual knowledge that it was contaminated.

Plaintiffs’ battery claims against the Premier Defendants are dismissed for failure

to state a claim.

c. Civil Conspiracy

As with the Tennessee Clinic Defendants, plaintiffs’ civil conspiracy claims

against the Premier Defendants do not adequately allege an underlying tort. See

Banco Popular N. Am v. Gandi, 876 A.2d 253 (N.J. 2005) (“Most importantly, the gist of

the claim is not the unlawful agreement, but the underlying wrong which, absent the

conspiracy, would give a right of action.”). Even if plaintiffs’ allegations that the

Premier Defendants conspired with NECC to violate Massachusetts pharmacy laws are

true, it is unclear that such violations give rise to an actionable tort for plaintiffs.

Plaintiffs also fail to allege facts regarding how the Premier Defendants conspired with


57

NECC, beyond generally stating that “upon information and belief the other Clinic

Related Defendants had similar communications [as STOPNC, Dr. Culclasure, and Ms.

Schamberg] with NECC.” Master Compl. at ¶ 349. Plaintiffs’ civil conspiracy claims are

dismissed.

d. Consumer Fraud

Plaintiffs allege that the Premier Defendants’ conduct constituted unfair or

deceptive acts or trade practices in violation of the New Jersey Consumer Fraud Act

(“NJCFA”), N.J.S.A. 56:8-1, et seq. Among other things, plaintiffs assert that the

Premier Defendants represented to their patients that “the products administered had

characteristics, uses and benefits that they did not have,” “failed to provide accurate

disclosures of all material information before Plaintiffs agreed to be injected with an

NECC Contaminated Drug,” “willfully and knowingly failed to abide by regulations, laws,

and guidelines set forth to protect consumer safety,” willfully and knowingly withheld

important safety information, concealed the MPA’s dangerous properties and risks, and

represented their patients were receiving FDA-approved Depomedrol instead of

NECC’s compounded MPA. Master Compl. at ¶¶ 246-253.

The Premier Defendants argue that health care providers are specifically

excluded from the NJCFA and thus those claims must be dismissed. They cite Macedo

v. Dello Russo, 840 A.2d 238 (N.J. 2004), in which the plaintiff alleged that her

physicians falsely represented that the doctors involved in her care were all fully

licensed with no limitations on their licenses. The N.J. Supreme Court held that


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“learned professionals” such as physicians were “beyond the reach of the [NJCFA] so

long as they are operating in their professional capacities,” including in advertising their

services. Id. at 242. Plaintiffs counter that the learned professional exception does not

apply because the Premier Defendants’ misconduct here was not a matter of

professional judgment or the quality of professional services related to patient

treatment. Rather, plaintiffs contend that the crux of their NJCFA claims is that the

Premier Defendants ordered and obtained for economic and convenience reasons, as

opposed to medical reasons, compounded prescription drugs from NECC through

illegally written prescriptions and then falsely passed off and billed the MPA as

Depomedrol.

However, even in these alleged deceptive acts and practices, the Premier

Defendants were not acting outside their professional capacities. The alleged conduct

all took place in the context of providing health care. See DiCarlo v. St. Mary Hosp.,

530 F.3d 255, 268 (dismissing plaintiff’s NJCFA claim that defendant hospital’s billing

practices were unreasonable and unfair); Hampton Hosp. v. Bresan, 672 A.2d 725 (N.J.

Super. Ct. App. Div. 1996) (granting summary judgment on patient’s NJCFA claim

against hospital alleging unlawful or unethical medical practices, implying the hospital

kept him against his will for economic as opposed to medical reasons). The situation

here is unlike other scenarios described in the case law as being “outside professional

capacity.” See, e.g., Macedo, 840 A.2d at 346 (“[I]f Dr. Dello Russo were to engage in

the merchandising of a golf course, a vacation time-share or a medical office building,


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he would be subject, as all merchandisers are, to the [NJ]CFA.”); Blatterfein v. Larken,

732 A.2d 555 (N.J. Super. Ct. App. Div. 1999) (architect’s activity as a real estate seller

is subject to the NJCFA).

Accordingly, plaintiffs’ NJCFA claims are dismissed.

e. Agency

Plaintiffs seek to hold the Premier Defendants vicariously liable for the conduct

of NECC, alleging that NECC was acting as the Premier Defendants’ agent. As with

the Tennessee Clinic Defendants, plaintiffs claim that a consensual fiduciary

relationship arose when the Premier Defendants contracted with NECC to procure

compounded drugs from NECC for their patients, and that NECC consented to act as

the Premier Defendants’ agent, and in their interest, when compounding and delivering

its drugs. See Master Compl., at ¶¶ 330-336. The master complaint also alleges that

the Premier Defendants controlled the procurement of the drugs from NECC and that

NECC acted within the scope of its agency when it negligently compounded drugs on

behalf of the Premier Defendants. Id.

New Jersey law “recognizes a vicarious liability principle pursuant to which a

master will be held liable in certain cases for the wrongful acts of his servants or

employees.” Carter v. Reynolds, 815 A.2d 460, 463 (N.J. 2003). In contrast,

employers are ordinarily not liable for the negligent acts of independent contractors in

the performance of a contract. Bahrle v. Exxon Corp., 678 A.2d 225, 231 (N.J. 1996).

To establish liability, a plaintiff must prove “(1) that a master-servant relationship


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existed and (2) that the tortious act of the servant occurred within the scope of that

employment.” Carter, 815 A.2d at 463. There are numerous factors used to determine

whether agency exists, see Carter, id. at 464 (citing factors from Restatement (Second)

of Agency, § 220), but the essential question is whether the employer exercised control

over “both the nature of the work performed and the manner in which the work is

completed,” Lowe v. Zarghami, 731 A.2d 14, 19 (N.J. 1999). The court in Lowe applied

a four-factor “control test” to determine a worker’s status as either an employee or

independent contractor: “(1) the degree of control exercised by the employer over the

means of completing the work; (2) the source of the worker’s compensation; (3) the

source of the worker’s equipment and resources; and (4) the employer’s termination

rights.” Id. at 19-20.

The Premier Defendants contend that these factors do not favor plaintiffs’ and

have not been adequately alleged in the complaint. They maintain that they did not

control the manner and means by which NECC performed its duties, including how

NECC cleaned its laboratories and where it manufactured medication. The Premier

Defendants acknowledge that they paid NECC for products and could have stopped

ordering medications from NECC at any time, but note that they had no role in

compensating or terminating NECC’s employees. They also point out that they did not

control or provide the equipment and resources used by NECC to manufacture MPA.

Indeed, the complaint contains no allegations indicating that the Premier Defendants

exercised any control over NECC or its conduct.


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Plaintiffs nevertheless argue that even if a party is deemed to be an independent

contractor as opposed to a servant or employee, a principal may still be held liable for

the contractor’s torts if it engages an incompetent contractor. Mavrikidis v. Petullo, 707

A.2d 977, 984 (N.J. 1998). Here, plaintiffs contend that they’ve sufficiently alleged that

NECC “was incompetent or unskilled to perform the job for which [it] was hired” and that

the Premier Defendants “knew or had reason to know of [NECC’s] incompetence.” Id.

Plaintiffs point to allegations in the master complaint regarding the general risks of

pharmacy compounding, NECC’s non-FDA approved status, NECC’s practice of selling

large quantities of drugs wholesale, often without patient specific prescriptions, and the

Premier Defendants’ purported knowledge of all these things. See Master Compl. at ¶¶

6, 48-53, 80-81, 159-162, 165-175, 178-182. However, as the Premier Defendants

point out, plaintiffs do not allege that NECC was an incompetent independent

contractor nor that the Premier Defendants were somehow aware of its incompetence.

Plaintiffs’ claims for vicarious liability against the Premier Defendants are

therefore dismissed.

f. Punitive Damages

Finally, the Premier Defendants argue that plaintiffs’ claim for punitive damages

must be dismissed. Under New Jersey’s Punitive Damages Act:

Punitive damages may be awarded to the plaintiff only if the plaintiff proves,by clear and convincing evidence, that the harm suffered was the result ofthe defendant’s acts or omissions, and such acts or omissions were actuatedby actual malice or accompanied by a wanton and willful disregard ofpersons who foreseeably might be harmed by those acts or omissions. Thisburden of proof may not be satisfied by proof of any degree of negligence,


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including gross negligence.

N.J.S.A. 2A:15-5.12. The Premier Defendants assert that while plaintiffs have alleged

recklessness and gross negligence, they have not pled facts to support egregious,

wanton, and willful conduct.

Plaintiffs, in contrast, insist that the master complaint is replete with factual

allegations demonstrating that the Premier Defendants’ conduct was willful and wanton,

beyond mere negligence or gross negligence. Plaintiffs do make various assertions in

the complaint that the Premier Defendants’ actions “went beyond mere

thoughtlessness, inadvertence or error of judgment,” Master Compl. at ¶ 237, and

“constituted such utter disregard for the rights of others, and such utter disregard for

prudence, that they amount to complete neglect for the safety of patients,” id. at ¶ 239.

They also allege that the Premier Defendants willfully and knowingly failed to abide by

consumer safety regulations and withheld important safety information from patients.

Id. at ¶ 249-50. Such allegations are enough to sustain plaintiffs’ punitive damages

claims at this early stage.

IV. Conclusion

(1) The Tennessee Clinic Defendants’ Motion to Dismiss for Failure to Comply withTenn. Code. Ann. § 29-26-121 (Docket # 770) and the Saint Thomas Entities’and Ascension Parties’ Motion to Dismiss for Failure to Comply with theTennessee Health Care Liability Act (Docket # 779) are DENIED with respect tothe limited questions presented by the parties.

As previously agreed by the parties, defendants may still seek dismissal basedon other, case-specific issues relating to the THCLA.


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(2) The Tennessee Clinic Defendants’ Motion Dismiss Global Claims (Docket # 771)is ALLOWED IN PART and DENIED IN PART as follows:

(a) DENIED as to products liability claims.

(b) ALLOWED as to claims under the Tennessee ConsumerProtection Act for recovery for personal injury or wrongful death,but DENIED as to such claims for the recovery of monies used topurchase MPA.

(c) ALLOWED as to battery claims.

(d) ALLOWED as to failure to warn (lack of informed consent claims)for defendants who did not order or administer injections, butDENIED as to all other defendants. Lack of informed consentclaims will be evaluated under the THCLA.

(e) DENIED as to claims for ordinary negligence, gross negligence,and duty to prevent foreseeable harm, but such claims will beevaluated under the THCLA.

(f) ALLOWED as to civil conspiracy claims.

(g) ALLOWED as to vicarious liability claims.

(3) The Saint Thomas Entities’ Motion to Dismiss Global Claims (Docket # 893) isDENIED. Plaintiffs’ vicarious liability claims are insufficient under the alter egotheory, but adequately pled under an agency theory.

(4) The Ascension Parties’ Motion to Dismiss Global Claims (Docket # 895) isALLOWED.

(5) The Premier Defendants’ Motion to Dismiss Global Claims (Docket # 831) isALLOWED IN PART and DENIED IN PART as follows:

(a) DENIED as to claims for negligence and failure to warn.

(b) ALLOWED as to battery claims.

(c) ALLOWED as to civil conspiracy claims.


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(d) ALLOWED as to claims under the New Jersey Consumer FraudAct.

(e) ALLOWED as to agency claims (vicarious liability).

(f) DENIED as to punitive damages claims.

August 29, 2014 /s/Rya W. Zobel DATE RYA W. ZOBEL

UNITED STATES DISTRICT JUDGE


district of massachusetts mdl no. 13-02419 …€¦ · in fall 2012, health officials ... # 176);...

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